Pfizer’s antiviral COVID-19 pill gets FDA approval

Antiviral pill can be taken at home prior to potentially needing to be hospitalized

Pfizer’s antiviral pill to treat COVID-19 was approved by the US Food and Drug Administration (FDA) on Wednesday. People sick at home with COVID-19 will be able to take the pill, called Paxlovid, before they may have to go the hospital.

The pill —which must be prescribed by a doctor — will be available for high-risk individuals who have tested positive for SARS-CoV-2, who are aged 12 and older and weigh at least 88 pounds, according to the FDA.

Individuals who are sick with COVID-19 will want to take the pill “as soon as possible” after testing positive for the virus and within five days of symptoms, the FDA said.

“Today’s authorization introduces the first treatment for COVID-19 that is in the form of a pill that is taken orally — a major step forward in the fight against this global pandemic,” said Patrizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research. “This authorization provides a new tool to combat COVID-19 at a crucial time in the pandemic as new variants emerge and promises to make antiviral treatment more accessible to patients who are at high risk for progression to severe COVID-19.”

Paxlovid — which is to be taken three pills at a time twice a day for five days — is a combination of a newly created antiviral drug called nirmatrelvir and a pre-existing drug called ritonavir.

Treatment with the newly approved drug has shown positive results, according to data released last week by Pfizer, which found it cut the risk of hospitalization or death in high-risk adults by 89% if taken within the first few days after symptoms, according to CNN Health.

The results were similarly positive if Paxlovid is taken within five days of symptoms occurring, showing an efficacy of 88%.

“Today’s authorization of PAXLOVID represents another tremendous example of how science will help us ultimately defeat this pandemic, which, even two years in, continues to disrupt and devastate lives across the world,” Pfizer Chairman and CEO Albert Bourla said in a statement. “This breakthrough therapy, which has been shown to significantly reduce hospitalizations and deaths and can be taken at home, will change the way we treat COVID-19, and hopefully help reduce some of the significant pressures facing our healthcare and hospital systems.”

The Biden administration announced in November that it would be purchasing 10 million treatment courses of Paxlovid for $5.295 billion.